Neofordex

dexamethasone

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This is a summary of the European public assessment report (EPAR) for Neofordex. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Neofordex.

For practical information about using Neofordex, patients should read the package leaflet or contact their doctor or pharmacist.

What is Neofordex and what is it used for?

Neofordex is a medicine used together with cancer medicines to treat adults with multiple myeloma who have developed symptoms. Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body’s natural defences).

Neofordex contains the active substance dexamethasone. It is a ‘hybrid medicine’. This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength. The reference medicine for Neofordex is Dectancyl.

How is Neofordex used?

Neofordex can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.

Neofordex is available as 40 mg tablets. The usual dose is 40 mg once a day, taken preferably in the morning. However, the dose and how frequently Neofordex is given varies depending on the medicines it is given with and the patient’s condition. For further information, see the package leaflet.

How does Neofordex work?

The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids. In multiple myeloma, Neofordex is used together with cancer medicines to kill cancerous plasma cells. It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death. Neofordex may also reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.

What benefits of Neofordex have been shown in studies?

Because the effects of high-dose dexamethasone in multiple myeloma are well established, the company for Neofordex presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.

In addition, a bioequivalence study was carried out in 24 healthy volunteers which showed that Neofordex has comparable quality to the reference medicine, Dectancyl.

What are the risks associated with Neofordex?

The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood sugar levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), tiredness, oedema (swelling) and weight increase. Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression. For the full list of all side effects reported with Neofordex, see the package leaflet.

Neofordex must not be used in patients with active viral disease (especially hepatitis, cold sores, shingles or chicken pox) or with uncontrolled psychoses (altered sense of reality). For the full list of restrictions, see the package leaflet.

Why is Neofordex approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established. The CHMP therefore decided that Neofordex’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Neofordex?

A risk management plan has been developed to ensure that Neofordex is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neofordex, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Neofordex

The European Commission granted a marketing authorisation valid throughout the European Union for Neofordex on 16 March 2016.

For more information about treatment with Neofordex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Neofordex : EPAR - Summary for the public BG = bălgarski 2016-04-01  
Neofordex : EPAR - Summary for the public ES = español 2016-04-01  
Neofordex : EPAR - Summary for the public CS = čeština 2016-04-01  
Neofordex : EPAR - Summary for the public DA = dansk 2016-04-01  
Neofordex : EPAR - Summary for the public DE = Deutsch 2016-04-01  
Neofordex : EPAR - Summary for the public ET = eesti keel 2016-04-01  
Neofordex : EPAR - Summary for the public EL = elliniká 2016-04-01  
Neofordex : EPAR - Summary for the public EN = English 2016-04-01  
Neofordex : EPAR - Summary for the public FR = français 2016-04-01  
Neofordex : EPAR - Summary for the public IT = italiano 2016-04-01  
Neofordex : EPAR - Summary for the public LV = latviešu valoda 2016-04-01  
Neofordex : EPAR - Summary for the public LT = lietuvių kalba 2016-04-01  
Neofordex : EPAR - Summary for the public HU = magyar 2016-04-01  
Neofordex : EPAR - Summary for the public MT = Malti 2016-04-01  
Neofordex : EPAR - Summary for the public NL = Nederlands 2016-04-01  
Neofordex : EPAR - Summary for the public PL = polski 2016-04-01  
Neofordex : EPAR - Summary for the public PT = português 2016-04-01  
Neofordex : EPAR - Summary for the public RO = română 2016-04-01  
Neofordex : EPAR - Summary for the public SK = slovenčina 2016-04-01  
Neofordex : EPAR - Summary for the public SL = slovenščina 2016-04-01  
Neofordex : EPAR - Summary for the public FI = suomi 2016-04-01  
Neofordex : EPAR - Summary for the public SV = svenska 2016-04-01  
Neofordex : EPAR - Summary for the public HR = Hrvatski 2016-04-01  
Name Language First published Last updated
Neofordex : EPAR - Risk-management-plan summary (English only) 2016-04-01  

This EPAR was last updated on 12/06/2018 .

Authorisation details

Product details

Product details for Neofordex
NameNeofordex
Agency product numberEMEA/H/C/004071
Active substance

dexamethasone

International non-proprietary name (INN) or common name

dexamethasone

Therapeutic area Multiple Myeloma
Anatomical therapeutic chemical (ATC) code H02AB02

Publication details

Publication details for Neofordex
Marketing-authorisation holder

Laboratoires CTRS 

Revision3
Date of issue of marketing authorisation valid throughout the European Union16/03/2016

Contact address:

Laboratoires CTRS 
63 rue de l’Est 
92100 Boulogne Billancourt 
France

Product information

Product information

28/05/2018  Neofordex -EMEA/H/C/004071 -IAIN/0007

Name Language First published Last updated
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12
Neofordex : EPAR - Product Information EN = English 2016-04-01 2018-06-12

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  
Neofordex : EPAR - All Authorised presentations EN = English 2016-04-01  

Pharmacotherapeutic group

Corticosteroids for systemic use

Therapeutic indication

Treatment of multiple myeloma.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Neofordex : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-08-02 2018-06-12

Initial marketing-authorisation documents

Name Language First published Last updated
Neofordex : EPAR - Public assessment report EN = English 2016-04-01  
CHMP summary of opinion for Neofordex EN = English 2015-12-18  

Authorised

This medicine is approved for use in the European Union

More information on Neofordex

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 9 June 2010. Neofordex was withdrawn from the Community register of orphan medicinal products in January 2016 upon request of the marketing-authorisation holder at the time of the granting of a marketing authorisation.